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Case Studies & Blogs
Real-world evidence needs real-world discipline: the FDA raises the bar
FDA issued a new guidance for medical devices and RWE. Applicability extends to drug development, regardless of the focus.
4 days ago5 min read
Adigens Health is growing: Come and join us!
Senior Manager in Epidemiology based in Ireland - opportunity of a lifetime to join a unique research organisation
Jan 82 min read
RWE in the era of N-of-1 medicines & ultra targeted therapies
Regulators are already approving ultra-targeted therapies on the basis of biological plausibility and tiny datasets.
Payers, meanwhile, are being asked to fund them at scale – often with little idea what they will deliver in real-world practice.
In the era of bespoke and ultra-targeted therapies, RWE can’t just mean a case series and a few registry plots. It needs to behave like a trial, even when no one is randomised.
Dec 9, 20257 min read
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